Acute Kidney Injury, Adverse Anesthesia Outcome, Adverse Effect of Other General Anesthetics, Anesthesia; Reaction
Conditions
Brief summary
The study hypothesis is that regional anesthesia offers better outcome for the patients who underwent robot assisted laparoscopic urogenital surgery.
Detailed description
The study investigates the effect of combined anesthesia on occurrence of acute kidney injury in robot assisted laparoscopic urogenital surgery.Renal function is assessed according to the new RIFLE and AKIN criteria, and by determining serum and urinary neutrophil gelatinase associated lipocalin.
Interventions
PROCEDUREepidural catheter insertion
A catheter is placed in the epidural space at thoracic level. Analgesia is realised with local anesthetics (Bupivacaine plain 0.125%), administered from the beginning of surgical intervention and 12 hours postoperative on the postoperative care unit and intensive care unit at a rate of 6-8 ml/hour.
PROCEDURErobot assisted laparoscopic urogenital surgery
The urogenital laparoscopic surgery is assisted by DaVinci robot. The majority of interventions were prostatectomies.
Sponsors
Iuliu Hatieganu University of Medicine and Pharmacy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* signed the informed consent without previous renal function alteration respiratory and hemodynamic stability
Exclusion criteria
* refuse to sign the informed consent chronic or and stage renal disease severe systemic diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| acute kidney injury | 4 days | Acute kidney injury, previously referred as acute renal failure is a serious complication of major surgery. The diagnostic of subclinical alteration of kidney function is possible with the novel biomarkers, such as neutrophil gelatinase associated lipocalin (NGAL). Modified NGAL values can be detected in patients urine and serum at 6 hours from the renal injury. In our study, we assessed the renal function by determining basal creatinine and follow the creatinine values 4 days postoperative. Acute kidney injury (AKI)is defined as a 0.3 mg/ml rise in serum creatinine from baseline, according to the AKIN criteria. NGAL is measured (with ELISA technique) at 6 hours and 12 hours from the induction of the anesthesia. The incidence of AKI will be compared in the different anesthesia techniques for robot assisted urogenital laparoscopic surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative outcome | 10 days | We study the effect of combined anesthesia (general anesthesia with epidural anesthesia and postoperative analgesia for 12 hours)on the postoperative outcome of patients who underwent robot assisted laparoscopic surgery. The endpoints that are discussed are perioperative morbidity, postoperative rehabilitation and the modification of host immune response to surgery. Postoperative rehabilitation is assessed by quality of recovery score (QoR-40). The modification of immune response is assessed by determining IL6, IL10 and TNFalfa levels. Post-prostatectomy increase in PSA (prostate specific antigen)indicates biochemic cancer recurrence. |
Countries
Romania
Contacts
Primary ContactOrsolya Mihaly, MD, Phd
Backup ContactSorana Bolboaca, MD, Phd
Outcome results
None listed